highlisted

Evidence Generation Evidence Records & Reuse Lead

IND - 2025 Takeda Biopharmaceuticals·Bengaluru

Pay not stated3–6 yrsFull-time

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About the role

Execute evidence-record centralization, maintenance and reuse-assessment activities within the Bengaluru GCM, ensuring records are complete, traceable and linked to approved evidence decisions Support other Strategy Leads in PRO/COA benchmarking, IEP coordination, and scenario planning in support of R&D, access, pricing, and commercial launch strategy decisions

What you'll do

  • Check record completeness against evidence repository requirements before upload
  • Upload evidence records to the designated central repository, applying naming conventions, tagging, access controls, and retention category assignments
  • Maintain evidence logs and version histories to support audit traceability and governance requirements; own ongoing repository hygiene including metadata integrity
  • Conduct structured searches across evidence repositories, prior studies, regulatory submissions, and existing evidence packages to identify potentially reusable evidence
  • Prepare reuse summary documents with source links, assumptions, and fit-for-purpose notes for review and final strategic decision by Global Evidence Generation

What you need

  • 3–6 yrs of experience
  • Regulatory affairs
  • Documentation
  • Any graduate

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